Mindful Attention Training for Pediatric Cancer Survivors

Overseen By Joaquin Anguera, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Motor difficulties, Perceptual difficulties, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new attention training program called Novel Mindful Attention Training to determine if it improves thinking and behavior in children who have survived cancer. Participants will either engage in a detailed at-home training program, a shorter version, or have no contact with the training, allowing for result comparison. The trial suits children who received radiation therapy to the brain or neck and are not currently undergoing active cancer treatment. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance cognitive recovery for young cancer survivors.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on cancer-related treatments, it will be discussed with the study team to see if it affects your participation.

What prior data suggests that this adaptive attention training is safe for pediatric cancer survivors?

Research has shown that programs like the new mindful attention training being tested can improve focus, memory, and thinking skills in children who have survived cancer. This training is generally easy to manage, as it involves no medical procedures and resembles mental exercises. No serious side effects have been linked to these programs, suggesting the treatment is likely safe. However, individual reactions may vary. Participants should always consult the trial team with any questions or concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Mindful Attention Training for pediatric cancer survivors because it offers a novel approach to improving attention and cognitive function, which can be affected by cancer and its treatments. Unlike traditional therapies that might focus on medication or cognitive rehabilitation, this method provides an at-home, adaptive training program that is both accessible and engaging for young patients. By allowing participants to complete the training at their own pace over 6-8 weeks, it empowers them to actively participate in their recovery process, potentially enhancing their quality of life with minimal disruption to their daily routines.

What evidence suggests that this trial's treatments could be effective for pediatric cancer survivors?

Research has shown that mindful attention training can improve thinking and behavior in cancer survivors. In this trial, participants will join different treatment arms to evaluate the effectiveness of this training. Studies have found that this type of cognitive training can boost brain function in cancer survivors. Mindfulness-based programs also reduce stress and anxiety, common among cancer survivors. This training may help people focus better and reduce mental distractions, potentially improving thinking skills. Early evidence suggests these non-drug methods hold promise for enhancing the quality of life in children who have survived cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Joaquin Anguera, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for children aged 7-17 who have survived pediatric cancer, can follow the study's procedures, and have a guardian to consent. They should speak English fluently, not be on certain cancer treatments that affect participation, and must have had radiation therapy to the brain or neck.

Inclusion Criteria

My vision and hearing are normal, or corrected to normal.

I am between 7 and 17 years old.

I, and if applicable, my legal guardian, can understand and are willing to sign the informed consent document.

Exclusion Criteria

Current cancer-related treatments that would impact the ability to participate in the study (e.g., current inpatient chemotherapy or intrathecal chemotherapy). Patients on other current treatments will be discussed with the study team (co-PI, Dr. Mueller)

Contraindication to any study-related procedure or assessment

You have difficulty using a computer or tablet due to problems with moving or understanding things.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete adaptive attention training ('Engage') for 6-8 weeks, with randomized cohorts completing either 15 hours or 1 hour of training.

6-8 weeks

Follow-up

Participants are monitored for cognitive and behavioral outcomes after completing the training.

4 weeks

No Contact Group Assessment

Participants in the no-contact group complete baseline and end-of-study assessments to evaluate assessment feasibility and reliability.

6-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Novel Mindful Attention Training

Trial Overview The study tests an adaptive attention training program against standard questionnaires to see if it improves thinking skills and behavior in kids who've beaten cancer. It's a pilot study which means it's preliminary research before larger studies.

How Is the Trial Designed?

Group I: No Contact Group (Not Randomized) Experimental Treatment 1 Intervention

An additional thirty participants will be enrolled separately (not randomized) into the no-contact group. Participants in the no-contact group will not complete any study activities for 6-8 weeks after completing the baseline assessments. After this period, participants will be prompted to log into Nexus to complete end of study assessments (same set of assessments administered/completed at baseline).

Group II: Adaptive Attention Training Experimental Treatment 2 Interventions

Participants will complete approximately 15 hours of an at-home training on a novel adaptive attention training program ('Engage'), which will consist of completing thirty, 30-minute sessions over a total of 6-8 weeks.

Group III: Low-dose Adaptive Attention Training Active Control 2 Interventions

Participants will complete approximately 1 hour of at-home training on 'Engage' which consists of two, 30-minute sessions at the beginning and middle of a 6-8 week period.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

Attention training shows promise in improving attention measures in children, particularly in those who have survived cancer affecting the central nervous system, experienced traumatic brain injury, or have attention deficit disorder, with six out of seven studies reporting positive outcomes.

The review includes a unique case study of a 6-year-old acute lymphoblastic leukemia survivor using attention training materials, marking a significant step in exploring interventions for young cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remediation of attention deficits in children: a focus on childhood cancer, traumatic brain injury and attention deficit disorder. Penkman, L.[2007]

In a study of pediatric brain tumor survivors, the 'daydreamy' aspect of Sluggish Cognitive Tempo (SCT) significantly predicted performance in speeded inhibition tasks, explaining 28% of the variance after accounting for verbal ability and inattention.

SCT did not significantly impact speeded naming or graphomotor speed, suggesting that SCT may particularly affect more complex cognitive tasks that require higher executive functioning in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Formula: see text]The contribution of sluggish cognitive tempo to processing speed in survivors of pediatric brain tumors. Peterson, RK., Jones, K., Jacobson, LA.[2021]

A pilot study involving 9 childhood cancer survivors showed that a 12-week home-based computerized cognitive training program significantly improved working memory and reduced attention problems.

The intervention was found to be feasible and acceptable, suggesting it could be a promising approach for addressing cognitive deficits in childhood cancer survivors, although larger studies are needed to confirm these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized cognitive training in survivors of childhood cancer: a pilot study. Hardy, KK., Willard, VW., Bonner, MJ.[2023]

A pilot study involving 31 off-therapy childhood cancer survivors showed that a cognitive remediation program (CRP) significantly improved attention and concentration in participants, with 21 completing the program and demonstrating better results than the comparison group.

While the CRP was effective in enhancing attentional measures, it did not lead to significant improvements in academic achievement, indicating that further research is needed to assess long-term benefits and applicability to other populations with cognitive impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attentional processes and their remediation in children treated for cancer: a literature review and the development of a therapeutic approach. Butler, RW., Copeland, DR.[2022]

About 28% of pediatric cancer survivors experience significant daytime sleepiness, which is linked to poorer neurobehavioral outcomes such as inattention, hyperactivity, and anxiety, as reported by both parents and teachers.

The study highlights the importance of assessing sleep functioning in annual care for cancer survivors, as sleep issues can negatively impact their behavior and emotional well-being in both home and school settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep and neurobehavioral functioning in survivors of pediatric cancer. Oswald, KA., Richard, A., Hodges, E., et al.[2021]

In a study of 29 children who underwent surgery for brain tumors, both those treated with radiation therapy (RT) and those who were not showed similar levels of attention performance and parent ratings at follow-up, suggesting that RT may not significantly impact attention outcomes in this group.

However, children with infratentorial tumors exhibited more inattention and inhibitory control errors on an auditory attention test compared to those with supratentorial tumors, indicating that tumor location plays a critical role in cognitive outcomes post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance-based and parent ratings of attention in children treated for a brain tumor: The significance of radiation therapy and tumor location on outcome. Raghubar, KP., Mahone, EM., Yeates, KO., et al.[2019]

In a study of 33 pediatric medulloblastoma survivors aged 7-18, parent-reported attention problems were significantly linked to social functioning, indicating that attention deficits can impact social skills in these survivors.

Self-reported attention ratings did not correlate with social functioning, suggesting that parents may have a better perspective on their child's attention issues compared to the children's self-assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of attention on social functioning in pediatric medulloblastoma survivors. Holland, AA., Colaluca, B., Bailey, L., et al.[2018]

In a study of 444 pediatric cancer survivors aged 6 to 17, those who received cranial radiation therapy (CRT) showed significant impairments in intellectual functioning, highlighting the long-term cognitive effects of this treatment.

Social economic status (SES) was found to be a strong predictor of both intelligence and attention, indicating that factors beyond medical treatment, such as family background, play a crucial role in cognitive outcomes for childhood cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intellectual functioning and multi-dimensional attentional processes in long-term survivors of a central nervous system related pediatric malignancy. Butler, RW., Fairclough, DL., Katz, ER., et al.[2013]

Survivors of leukemia and CNS tumors often experience significant neurocognitive late effects, including deficits in attention, memory, and executive function, highlighting the need for effective interventions as these children live longer.

Cognitive training programs, adapted from techniques used for adults with traumatic brain injuries, are being developed and researched to help improve cognitive functioning in pediatric cancer survivors, with ongoing evaluations of their effectiveness and feasibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive training programs for childhood cancer patients and survivors: A critical review and future directions. Olson, K., Sands, SA.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05000905

Improving Cognition and Behavior in Pediatric Cancer ... This pilot study will evaluate the cognitive and behavioral outcomes of using a novel, adaptive attention training in pediatric cancer survivors. Detailed ...

2. withpower.com withpower.com/trial/mindful-attention-training-for-pediatric-cancer-survivors-18130

Mindful Attention Training for Pediatric Cancer Survivors This pilot study will evaluate the cognitive and behavioral outcomes of using a novel, adaptive attention training in pediatric cancer survivors. Show more.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05000905/improving-cognition-and-behavior-in-pediatric-cancer-survivors-using-a-novel-mindful-attention-training

Improving Cognition and Behavior in Pediatric Cancer ... This pilot study will evaluate the cognitive and behavioral outcomes of using a novel, adaptive attention training in pediatric cancer survivors

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11794363/

The effect of non-pharmacological interventions on cognitive ... Overall, cognitive training/rehabilitation interventions were found to be effective for improving cognition in cancer survivors across various ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8200136/

Mindfulness-Based Interventions in Cancer Survivors Following the 6-week MBSR program, patients showed improvements in stress and anxiety. Patients also had significant decreases in cortisol at ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7117751/

Advances in Pediatric Psycho-Oncology - PMC One recent study found that a novel year-long musical training intervention improved symptoms of depression and enhanced self-esteem and quality of life [21].

7. sciencedirect.com sciencedirect.com/science/article/pii/S1878929318301208

Future considerations for pediatric cancer survivorship There is a growing body of work that has used cognitive training programs to increase attention, memory, and cognitive flexibility in pediatric cancer survivors ...